Director, Pharmacovigilance
Cabaletta Bio
August 30, 2026
Remote friendly (Philadelphia, PA)
United States
Operations
Position Description
- This role can be based out of Philadelphia, PA headquarters (hybrid) or remote.
Reporting into the VP, Clinical Development, the Director, Pharmacovigilance leads and executes global safety and pharmacovigilance activities across clinical-stage CAR-T programs in autoimmune diseases. Responsible for high-quality safety data collection, analysis, and reporting in compliance with global regulatory requirements, partnering cross-functionally to support clinical development and future regulatory submissions.
Key Responsibilities
- Lead pharmacovigilance strategy across clinical programs and serve as safety lead on study teams for safety data interpretation and risk management.
- Contribute to safety-related documents (DSURs, IBs, protocols, and safety sections of regulatory submissions such as INDs/BLAs).
- Oversee case processing (SAE review, medical assessment, timely reporting).
- Lead signal detection, evaluation, and risk assessment (aggregate data review and benefit-risk evaluation); ensure escalation/communication of safety signals to stakeholders and governance committees.
- Ensure compliance with FDA, EMA, and ICH pharmacovigilance regulations; support health authority interactions and inspection readiness/audits/inspections.
- Partner with Clinical Development, Clinical Operations, Regulatory, and Medical Affairs; provide safety input into trial design/study conduct/data review; collaborate with CROs and safety databases.
- Establish/refine PV processes and oversee PV vendors; build scalable PV capabilities.
Qualifications
- MD, PharmD, PhD, or equivalent (preferred).
- 8–10+ years pharmacovigilance/safety experience in biotech/pharma (including clinical-stage programs).
- Strong knowledge of global pharmacovigilance regulations (FDA/EMA/ICH).
- Clinical trials experience: safety monitoring, signal detection, aggregate reporting (e.g., DSURs).
- Prior cell/gene therapy and/or immunology experience strongly preferred.
- Cross-functional influence in matrix environments; strategic and hands-on capability in a fast-paced setting.
- Analytical, communication, problem-solving skills; strong attention to detail and commitment to quality/patient safety.
- This role can be based out of Philadelphia, PA headquarters (hybrid) or remote.
Reporting into the VP, Clinical Development, the Director, Pharmacovigilance leads and executes global safety and pharmacovigilance activities across clinical-stage CAR-T programs in autoimmune diseases. Responsible for high-quality safety data collection, analysis, and reporting in compliance with global regulatory requirements, partnering cross-functionally to support clinical development and future regulatory submissions.
Key Responsibilities
- Lead pharmacovigilance strategy across clinical programs and serve as safety lead on study teams for safety data interpretation and risk management.
- Contribute to safety-related documents (DSURs, IBs, protocols, and safety sections of regulatory submissions such as INDs/BLAs).
- Oversee case processing (SAE review, medical assessment, timely reporting).
- Lead signal detection, evaluation, and risk assessment (aggregate data review and benefit-risk evaluation); ensure escalation/communication of safety signals to stakeholders and governance committees.
- Ensure compliance with FDA, EMA, and ICH pharmacovigilance regulations; support health authority interactions and inspection readiness/audits/inspections.
- Partner with Clinical Development, Clinical Operations, Regulatory, and Medical Affairs; provide safety input into trial design/study conduct/data review; collaborate with CROs and safety databases.
- Establish/refine PV processes and oversee PV vendors; build scalable PV capabilities.
Qualifications
- MD, PharmD, PhD, or equivalent (preferred).
- 8–10+ years pharmacovigilance/safety experience in biotech/pharma (including clinical-stage programs).
- Strong knowledge of global pharmacovigilance regulations (FDA/EMA/ICH).
- Clinical trials experience: safety monitoring, signal detection, aggregate reporting (e.g., DSURs).
- Prior cell/gene therapy and/or immunology experience strongly preferred.
- Cross-functional influence in matrix environments; strategic and hands-on capability in a fast-paced setting.
- Analytical, communication, problem-solving skills; strong attention to detail and commitment to quality/patient safety.